English; Intended Use / Indications; Product Description; Contraindications - baxter prismaflex TPE1000 SET Notice D'utilisation

BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: 1000014992
Designer: CDS
Colour Reference:
BLACK

ENGLISH

The Prismaflex TPE1000/TPE2000 set is manufactured by GAMBRO
Industries, 7 avenue Lionel Terray, BP 126, 69883 MEYZIEU CEDEX, FRANCE.
Caution: Federal law (USA) restricts this device to sale by or on the
order of a physician.
DEFINITION OF EXPRESSIONS USED
IN THIS MANUAL
In this document :
"Warning" indicates a hazardous situation which, if not avoided, could result in
death or serious injury.
"Caution" indicates a hazardous situation which, if not avoided, could result in
minor or moderate injury.
"Note" to give additional information.
TPE Therapeutic Plasma Exchange.
"Control unit" refers to the PrismaFlex control unit, or to the PrisMax control unit
(in countries where PrisMax is cleared or registered).

PRODUCT DESCRIPTION

• The Prismaflex TPE1000/TPE2000 set is a disposable, extracorporeal circuit
for use with the PrismaFlex control unit or with the PrisMax control unit
(in countries where PrisMax is cleared or registered) having selected 'TPE'
therapy.
• The Prismaflex TPE1000/TPE2000 set consists of a polypropylene hollow fiber
plasmafilter*and tubing lines; refer to the control unit operator manual drawing
for details.
• The blood return line (blue-striped) is equipped with a Luer-lock connection
near the deaeration chamber, dedicated to the connection of authorized
devices and accessories described in the control unit operator's manual.
• All line connectors are compatible with the ISO 594-1 and ISO 594-2
international standards concerning conical fittings.
• The fluid pathways of the Prismaflex set are guaranteed sterile and non
pyrogenic.
• The Prismaflex set is sterilized by ethylene oxide (EtO). Deaeration is such that
EtO residuals comply with standards in ISO 10993.
• Expiration date: please refer to product label.
* In this document the plasmafilter will be referred to as "filter".

INTENDED USE / INDICATIONS

The Prismaflex TPE1000/TPE2000 set is indicated for use only with the
PrismaFlex control unit or with the PrisMax control unit (in countries where
PrisMax is cleared or registered), after having selected TPE therapy (therapeutic
plasma exchange).
The Prismaflex TPE1000/TPE2000 set is intended for use in therapeutic plasma
exchange, thus in diseases where removal of plasma components in indicated.
The use of the Prismaflex TPE1000 set should be restricted to patients with a
body weight greater than 9kgs (20lbs).
The use of the Prismaflex TPE2000 set should be restricted to adults.
The size, weight, state of uremia, cardiac status and general physical condition of
the patient must be evaluated by the prescribing physician before each treatment.
The device should be used only on the direction of a physician who has
evaluated all of the pertinent features of this device in relation to the individual
patient. Patients with bleeding tendencies must be closely supervised during the
treatment.
Treatment should be discontinued if acute hemorrhage that can not be corrected
(hematemesis, hemoptysis and melena) occurs during TPE.
All treatments administered via the Prismaflex set must be prescribed by a
physician.

CONTRAINDICATIONS

There are no known absolute contraindications to therapeutic plasma exchange.
For the following conditions a careful assessment of the individual risk/benefit
ratio has to be made by the treating physician (relative contraindications):
• Inability to establish vascular access,
• Severe hemodynamic instability
Known hypersensitivity to any component of the Prismaflex set.
•
Date: 02-NOV-2020 Proofread No.: 1
Page: 14 of 80

CAUTIONS AND WARNINGS

Note: refer to the control unit user interface and operator's manual for additional
cautions and warnings.
Cautions
1. Particular attention must be paid to extra corporeal blood volume with respect
to patient size. Consider the sum of the Prismaflex set blood volume (refer to
"Specifications") plus the blood volume of any accessory or device if used.
2. If the patient is not immediately connected to the Prismaflex set after priming is
complete, flush the set with at least 1 000 mL priming solution [saline or alkaline
solution (pH ≥ 7.3) with or without heparin added according to usual institutional
practice] prior to connecting the patient. This requires use of a new bag of
priming solution.
3. When not using the pre blood pump infusion circuit, it is recommended to
clamp this circuit close to its connection to the access line; this will prevent the
sedimentation of blood into the pre blood infusion line
4. Using the Prismaflex set with blood flow rate lower than the recommended
minimum values (see "Operating Parameters" section) may impair filter
performance due to hemoconcentration, or to increased risk of coagulation.
5. Since drugs can be removed by the membrane of the filter, the dosage of
associated drug treatments may need to be adjusted for patients on TPE
therapy. Monitoring of blood drug levels of relevant compounds should be
performed. The removal of other watersoluble compounds (e.g. vitamins, trace
elements) during therapy also requires clinical consideration.
Warnings
1. Carefully read these instructions for use and the control unit operator's manual
before using this product.
2. The use of operating procedures other than those published by the
manufacturer or the use of accessory devices not recommended by the
manufacturer can result in patient injury or death.
3. Store the Prismaflex set in a dry place, between 0° C (32° F) and 30° C
(86° F).
4. Do not use this set if the packaging is damaged, if the sterilization caps are
missing or loose, or if any of the lines in the set are kinked.
5. To prevent contamination, this Prismaflex set must be used as soon as its
packaging and sterilization caps are removed.
6. Do not try to remove the filter from the cartridge plate.
7. Use aseptic techniques when handling all blood and fluid lines in the set.
8. Prismaflex sets are compatible with the usual disinfection agents used for
aseptic setup; however solvents and other chemicals, if used in contact with
the product, could damage the set.
9. During priming and operation, observe closely for leakage at joints within the
set, and connections to other approved accessories and bags. Leakage can
cause blood loss, fluid imbalance or air embolism. If a leakage is detected at
a Luer connection and cannot be stopped by tightening the connections, or if
leakage occurs at any other location, replace the set
10. Tightening Luer connections with an excessive force can damage the
connectors.
11. In the case of patients who pose a high risk of hemorrhage it is recommended
not to add heparin to the priming solution.
12. Do not allow air to enter the blood compartment of the filter after priming is
started. If a large amount of air enters, the set must be replaced.
13. Only use this set with the control unit in TPE mode. Use of this set with any
CRRT therapy can result in patient injury or death.
14. Should acute allergic reactions (first-use syndrome) occur in patients receiving
treatment via the Prismaflex TPE1000/TPE2000 set, immediately stop the
treatment and administer appropriate intervention. Pay special attention to
patients having already shown similar allergic reactions (see "Hypersensitivity
Reactions" section).
15. Use a 21-gauge or smaller needle to obtain blood/fluid samples or remove
trapped air from the Prismaflex set. Use of larger needles can cause holes in
the sample sites, resulting in external leak or air intake.
16. External blood leakage may not be immediately identified by monitoring
equipment and could result in significant blood loss. Check the filter and all
connections of the disposable tubings during treatment to minimize the risk of
leakage.
17. To avoid complications due to increase of blood viscosity, the post-filler
hematocrit (hematocrit in patient blood return) should never exceed 65%.
18. In some cases hemolysis may occur (pink or red tinge in the effluent bag) but
may not be detected by a control unit alarm. When performing TPE, monitor
the effluent bag closely (see "Special Procedures" section on "Hemolysis").
19. Reference literature* and laboratory data have shown an increase in the
plasmafilter pressure drop over time when the anticoagulation level (heparin)
is insufficient. Such a situation increases hemolysis rate and the likelihood of
TMPa alarms. Carefully monitor the hemolysis and anticoagulation strategies
in such circumstances.
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